Review of New Platforms for Blood Prime

Edwin A. Burgstaler, MT, HP(ASCP)

ASFA 2015 Annual Meeting May, 2015

©2015 MFMER | slide-1 Blood (Custom) Prime Objectives • The participant will recognize the basic steps in performing a blood prime of apheresis instruments • The participant will be able to recite advantages of the new custom prime feature in the Spectra Optia and Amicus apheresis instruments

• Extracorporeal volume (ECV) is the blood outside the body • Machine ECV + warmer volume >15% of patient TBV • Machine ECV + warmer volume >10% of patient TBV

©2015 MFMER | slide-3 Blood (Custom) Prime Major Considerations - TBV • Patient total blood volume (TBV) • Patient weight >25 kg (55 lbs): Use machine algorithm (Nadler formula) except boys <10 years and < 30 kg (66 lbs) have a smaller TBV* • Patient weight > 9.1 kg - <25 kg (20-55 lbs): Use 80 ml/kg x patient weight in kg = TBV of patient • Patient weight <9.1 kg (20 lbs): Use 90 ml/kg x patient weight in kg = TBV of patient • Machine extracorporeal volume (ECV) • From operator’s manual

Blood (Custom) Prime Major Considerations – RBC Volume • Patient RBC volume Patient HCT x patient total blood volume = patient RBC volume • Machine extracorporeal RBC volume From operator’s manual • RBC prime necessary? • Acceptable peripheral HCT while on machine [(Pt HCT x TBV) – RBC in machine] ÷ TBV= new pt HCT • Up to 30% acceptable, if isovolemia is maintained* • Variable RBC content – Amicus MNC collection *Kim HC. Therapeutic pediatric apheresis. J Clin Apheresis2000;15:129-157. ©2015 MFMER | slide-5 Blood (Custom) Prime Machine Volumes (without warmer)

Total ECV (mL) RBC ECV (mL) Optia Exchange 185 185 x patient HCT

Optia Collection 191 191 x patient HCT

Amicus TPE 160 73

Amicus MNC 163 79-122

Spectra Exchange 285 68

Spectra WBC 285 114

• Blood with RBC • Blood with preservative solution ( 53% HCT) • Packed RBC ( 80% HCT) • Customized HCT blood ( patient HCT) • Normal serum albumin • Protein rather than crystalloid replacement • Consider not diverting prime • Plasma • Source of clotting factors (pre surgery) • Source of other plasma proteins • Consider not diverting prime

©2015 MFMER | slide-7 Blood (Custom) Prime Basic Steps • Determine if prime will be needed • Determine the prime fluid - blood, plasma, albumin • If blood, select and crossmatch the appropriate unit of blood • Correct volume • HCT adjusted (if needed) • Determine the anticoagulant type • ACD-A with calcium supplement • Heparin with ACD-A, with or without calcium supplement • Heparin only (primarily filtration)

©2015 MFMER | slide-9 Blood (Custom) Prime Basic Steps (cont. 1) • Prime the machine normally with normal saline and AC • Prepare waste bag • Seal off line close to bag • Attach a sampling site coupler (needle or needle- less) • Attach a sampling site coupler to blood bag • Attach inlet line to blood bag • Use lever lock cannula to needle-less coupler • Use large needle for needle coupler • Attach return line with warmer to waste bag • Use lever lock cannula for needle-less coupler • Use large needle for needle coupler

©2015 MFMER | slide-10 Blood (Custom) Prime Basic Steps (cont. 2) • Open clamps and start “procedure” • Can increase speed for blood prime by changing patient data • Process until return line same color as inlet line or blood bag empty • Stop “procedure” • Clamp lines, disconnect inlet line and attach to patient • Clamp lines, disconnect return line with warmer to patient • Correct patient data if previously changed • Record inlet volume, AC volume, replacement volume (TPE), procedure time • Ready to start actual procedure on patient • Usually do not reinfuse or rinseback

©2015 MFMER | slide-12 Blood (Custom) Prime Amicus MNC Considerations • All storage plasma and transfer plasma collected early • Usually not all is collected before prime done • Collected “plasma” is actually RBC preservative solution • RBC preservative solution will be used for cycle transfers • RBC preservative solution could be used for freezing • RBC used to transfer cells for each cycle (about 35 ml)

©2015 MFMER | slide-13 Blood (Custom) Prime Amicus MNC – Addition of RBC During Transfer • Patients < 10 kg • 1 unit pRBC + 200 ml 5% NSA as RBC source • 2-6 cycles, average 3 cycles • Primed with RBC source • During each cycle “RBC collection”, opened stopcock to RBC source • During entire “mini-cycle” opened stopcock to RBC source • Transfused about 36 ml pRBC with each cycle • “Mini-cycle” processed about 160 ml Witt V, et al. Performance of a New Separator System for Routine Autologous Hematopoietic Progenitor Cell Collection in Small Children. J

Blood (Custom) Prime Amicus MNC Collection Alternative • Program realistic number of cycles, no storage plasma • After plasma collection is complete, program storage plasma • Program 10 ml/kg patient weight plus 20 ml storage • Storage plasma will be collected after minicycle – few platelets • Stop storage plasma transfer at 20 ml • Send product and plasma to processing lab • Lab spins down product, removes and discards the RBC preservative plasma • Storage plasma is used for cryopreservative • Benefits fluid balance – plasma removed vs AC given

©2015 MFMER | slide-15 Blood (Custom) Prime Fenwal Amicus Custom Prime Benefits • Need version 4.5 or greater software • Machine recommends custom prime when indicated by kit volume and TBV • Machine knows it is a separate prime procedure • Once 85 ml pumped, “stop custom prime” is enabled, once 200 ml pumped, pumps stop, can continue prime or stop prime • Faster speeds used for prime (100 ml/min for 200 ml) • Machine will zero all numbers when start patient • Machine will default to no reinfusion, can be changed • RBC preservative solution returned to patient, plasma is collected after initial processing

©2015 MFMER | slide-16 ©2015 MFMER | slide-17 Blood (Custom) Prime Spectra Optia Custom Prime Benefits • Machine recommends custom prime when indicated by RBC volume and TBV of patient data entered • Machine knows it is a separate prime procedure • Machine will pump at least 200 ml and warmer volume of priming solution, but can be extended • Faster speeds will be used for the prime • Machine will zero all numbers when start patient • Machine will default to no rinseback, but can be changed

©2015 MFMER | slide-18 Blood (Custom) Prime Reinfuse or Not? • Will add to positive fluid balance • Depends on need of RBC for patient • Patient will receive their own RBC, not banked blood • Could do partial reinfusion/rinseback

©2015 MFMER | slide-19 Blood (Custom) Prime Partial Reinfusion on Amicus • TPE • Complete Reinfusion= about 170 ml + warmer • When the right lower pump stops, most of the concentrated RBC have been returned • MNC • Complete reinfusion= about 263ml + warmer • Approx 40 ml in the lines drain by gravity; 125 ml saline +blood from waste bag, middle cassette, and cent pack are pumped(about 2 min after return pump starts if using 50ml/min rate); would be about 165 ml. ©2015 MFMER | slide-20

Blood (Custom) Prime Partial Rinseback on Optia • TPE • Complete Rinseback = about 110 ml + warmer • Go to Rinseback, first 60ml is undiluted RBC, monitor fluid balance on screen, stop manually (press Pause) • MNC • Complete Rinseback = unknown • Go to Rinseback, first 60ml undiluted RBC, monitor fluid balance on screen stop manually (press Pause)

©2015 MFMER | slide-21 Blood (Custom) Prime Fluid Balance • TPE – Can adjust with replacement fluids • MNC – Large volume AC, low volume product • Reinfusion adds to positive fluid balance • Optia: Could collect plasma intermittently during collection • Amicus: Collect plasma at end of procedure (10 ml/kg patient weight)

• Blood prime allows small patients to be eligible for apheresis procedures • Performance of a blood prime is not difficult • The new custom prime programs help simplify the priming process